RELIANCE: Moringa in Lactation and Early Childhood

NCT07605091 | Not Yet Recruiting

• 1 other identifier: 108194
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the impact of maternal moringa supplementation to mothers of breastfeeding infants on milk output, milk composition, exclusive breastfeeding duration, and maternal and child health. This will be accomplish by conducting a randomized, controlled dietary intervention study enrolling breastfeeding mothers and their newborn infants. Mothers will be randomized to receive either 10g dried moringa leaf powder in carrier vs. carrier alone, consumed daily for four months, with follow-up for 2 years. Women must be \>18 years of age, ≤ 21 days postpartum and currently lactating at the time of enrollment. Infants must be at least 37 weeks of gestational age, be healthy and are able to feed orally and consume human milk. After randomization and enrollment, breast milk samples will be obtained at baseline, 2, 4, 6, 9 and 12 months. Serum from mothers will be collected at recruitment, 2, 4, 6,and 12 months; infant serum will be collected by capillary sample at recruitment and approximately at 2, 6, 12, and 24 months. Infant feeding weights (test weights) will be collected on sequential days at recruitment, 4, and 6 months. Dietary recall: the foods and drinks consumed by mothers in the past month prior to each milk sample. Other assessments will include perceptions of breastfeeding, assess complementary feeding practices. Review will be conducted of maternal and infant infections, diagnoses, and hospitalizations at the time of visit or since the last visit.

Conditions

Breast Feeding; Lactation

Outcome Measures

Primary Outcomes (2)

• Human Milk Production (milk volume)

  Human milk production measured by 24-hour infant test-weighing to estimate daily milk volume.

  Baseline, 2 months, 4 months, 6 months, 9 months and 12 months

• Duration of Exclusive Breastfeeding

  Duration of exclusive breastfeeding assessed by maternal report.

  Up to 12 months

Secondary Outcomes (3)

• Maternal Serum Levels of Estradiol

  Baseline, 2 months, 4 months, 6 months and 12 months

• Maternal Serum Levels of Progesterone

  Baseline, 2 months, 4 months, 6 months, and 12 months

• Maternal Serum Levels of Prolactin

  Baseline, 2 months, 4 months, 6 months, and 12 months

Study Arms (2)

Carrier and Moringa Leaf Powder

EXPERIMENTAL

Dietary Supplement: Moringa Leaf Powder

Carrier

PLACEBO COMPARATOR

Other: Carrier

Interventions

Moringa Leaf Powder DIETARY_SUPPLEMENT

Participants randomized to Moringa will consume 10 grams each day of the Moringa leaf powder mixed into porridge.

Carrier and Moringa Leaf Powder

Carrier OTHER

Participants randomized to the control will be given porridge without Moringa.

Carrier

Eligibility Criteria

• Age: 7 Days - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants: must be born at term (=37-42 weeks), singleton birth, lactating, age 7-21 days at enrollment

You may not qualify if:

• Mothers - women reporting regular consumption of moringa in the last month (\>1 time weekly), unable to consume moringa or unable to complete study activities within the first two weeks.
• Mothers - Women with a contraindication to Moringa use (blood thinners, levothyroxine, antihypertensive treatments, insulin dependency).
• Infants - significant congenital disease, are unable to feed orally.

Sponsors & Collaborators

• Philip Kern: lead

Study Sites (1)

SUNDY Downstate

Brooklyn, New York, 11203, United States

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Carrier State

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Public Health; Environment and Public Health

Central Study Contacts

Philip Kern

CONTACT

8593232615; pake222@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

US (1)